Quality and Standards Manager - ATMPs
Home based - UK Wide
c£60,000 + Bonus +Benefits
Do you have QA or Quality experience relating to the manufacture and supply of Advanced Therapy Medicinal Products (ATMPs)?
Would you like to work for a leading organisation at the forefront of the development and commercialisation of gene and cell therapy products?
My client, based in London, are specialists in the Research, Development and Commercialisation of Advanced therapy medicinal products, working with Biotechnology and Biopharmaceutical companies to translate early stage research into quality, commercially viable, scalable and investable therapies. They attract leading scientists from around the world, to join their R&D department, which boasts state of the art laboratories and facilities supporting Gene Therapy & Cell Therapy development and industrialisation.
Due to continued growth they are looking to hire a Quality and Standards Manager - ATMPs to drive quality-based standardisation and best practise across the manufacture and supply to patients of cutting edge and novel ATMPs. This role of Quality and Standards Manager - ATMPs will work with numerous industry based partners and stakeholders from Big Pharma and SME Biotech companies alike, optimising harmonisation of practices in-line with Quality and Regulatory standards and considerations.
Areas of consideration for the Quality and Standards Manager - ATMPs will be within areas such as the collection of human starting materials for the manufacture of ATMP, production and testing of therapeutics, supply chain solutions, labelling, NHS practice, diagnostic tools and traceability.
The role will be home based, however there will be the requirement to visit the head office in London a couple of times a month. There will also be some infrequent travel to conferences and meetings within the UK.
To be considered for the role of Quality and Standards Manager - ATMPs you will need the following skills and experience;
- Understanding of the quality and regulatory requirements for ATMP manufacture and supply
- Experience of supply of Medical Products into the NHS, either from starting material procurement, clinical trial and marketed product delivery
- Experience in running multi-stakeholder projects
- An understanding of supply to the NHS
- Experience of PowerPoint presentations and generating Executive/Board reports
- Flexible and pragmatic, able to learn quickly and respond to project needs and priorities
- Ability to present highly complex and sensitive or contentious information, where there are significant barriers to understanding
- Resolve problems and communicate well
- A flexible approach to work assignments with an ability to manage multiple and varied tasks and to prioritise the workload whilst maintaining attention to details
- Analytical and conceptual thinking skills
- The ability to influence senior stakeholders and to work closely with them to determine acceptable solutions
- Ability to work quickly and accurately, with limited supervision
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives
- A good team player
The role is home based so you could be based in London, Surrey, Oxford, Cambridge, Birmingham, Manchester, Liverpool or anywhere across the UK, so long as you have the ability to get to London a couple of times a month.
Key Words "QA Manager, Quality Manager, Quality Assurance, Regulatory, QA/RA, ATMP, Biologics, Advanced Therapeutic Medicinal Product, Gene Therapy, Cell Therapy, Standardisation, 3rd party, Manufacturing, Production, GxP, GMP, GDP, labelling, packaging, Biopharmaceutical, Pharmaceutical"
You must be eligible to work in the UK. Learn more
- Agency: SRG
- Reference: J2156807
- Posted: 12th October 2020
- Expires: 9th November 2020